CPAP for Esophageal Cancer With Radiotherapy

NCT ID: NCT06037902

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2027-09-30

Brief Summary

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The goal of this clinical trial is to test the use of CPAP in patients with esophgaeal cancer undergoing radiotherapy.

The main questions it aims to answer are:

* does use of CPAP decrease exposure of normal lung to radiation?
* does use of CPAP decrease exposure of normal heart to radiation?

Participants will undergo simulation twice:

* with CPAP
* without CPAP

Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

all patients undergo two simulations.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP

patients will undergo simulation twice, with and without CPAP

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

patients undergo simulation twice, with and without CPAP

Interventions

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CPAP

patients undergo simulation twice, with and without CPAP

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of cancer, with a tumor (primary or secondary) in the esophagus including tumors in the esophagus-stomach junction.
2. Age ≥ 18
3. Planned RT treatment
4. The level of functioning ≥ 60 on the Karnofsky scale
5. Life expectancy ≥ two months
6. All patients must understand the informed consent form document and sign it of their own free will before any test/procedure related to the study is performed.
7. Able to undergo simulation and radiation with CPAP
8. Candidate patients can be recruited to receive definitive, palliative or pre-operative radiation, with or without chemotherapy.

Exclusion Criteria

1. Pregnancy or breastfeeding
2. Significant comorbidity at the starting point that would prevent the use of CPAP
3. Hospitalized in an institution by virtue of an administrative order or a court order.
4. Special population
5. A history of a psychiatric problem that may impair the patient's ability to understand the research requirements or respond to them, or to give his consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Yaacov Lawrence

Chair of Department of Radiation Oncology, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Yaacov R Lawrence, MBBS MA MRCP

Role: primary

97235304410

Aliza Ackerstein

Role: backup

035308402

Other Identifiers

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SHEBA-22-0032-YL-CTIL

Identifier Type: -

Identifier Source: org_study_id

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